In the field of clinical research, pharmacovigilance represents the analysis and monitoring of drugs and medications to prevent adverse effects. In order to ensure drug safety and prevent adverse events, Health Canada has generated a list of strict practices and guidelines that must be followed by clinical research professionals and drug manufacturers. The health authority also has an inspection program in place to provide independent oversight and evaluation of manufacturer adherence to mandated reporting of adverse drug reactions, and of any efficacy failures found in new drugs.
To understand more on the need to employ pharmacovigilance practices, and what some of those are, let’s take a closer look.
The Importance of Pharmacovigilance
Health Canada mandates that drug manufacturers follow strict pharmacovigilance regulations in order to ensure the safety of Canadian citizens requiring medications. The monitoring aspect of pharmacovigilance is also helpful in revealing added benefits experienced by the person taking the drug. Those enrolled in clinical research training might best understand pharmacovigilance processes by placing them into the following divisions:
- Operations Division: involves gathering data during the pre-clinical and clinical trial phase of a drug’s development, as well as data on any reports from doctors and patients of adverse events
- Monitoring Division: analysis of the data collected at the operations phase, creating safety development update reports for drugs, and creating benefit-risk evaluation reports
- Systems Division: responsible for keeping up to date on rules and regulations to build a solid system for accessing all required safety data
A Closer Look at Reporting Requirements for Those Taking Clinical Research Training
Any observations made by drug manufacturers through pharmacovigilance practices, whether positive or negative, are reported under Health Canada’s regulations, allowing issues to be resolved and improvements to be introduced as quickly as possible. The drugs for human use that must be monitored under Health Canada’s pharmacovigilance guide include:
- Biologics, including biotechnology products and vaccines
- Medical gases
The Ultimate Purpose of Pharmacovigilance Efforts
If you’re in a clinical research program, you’re likely interested in learning about the benefits that can be gained from pharmacovigilance. The number one benefit of monitoring drug efficacy and safety is a better outcome for patient safety and wellbeing. By monitoring the drug throughout its life cycle, from pre-clinical development to post-market monitoring, important data is gathered and reported to Health Canada to determine which adverse events are acceptable when weighed against the drug’s benefits.
Deriving conclusions on patient safety from the data, drugs will at times be permanently removed from the market, or a clinical trial of a drug in development may be discontinued. This important process of drug development ensures the right of every Canadian citizen to have their safety and wellbeing safeguarded.
Are you interested in learning more about pharmacovigilance by earning your clinical research diploma?
Contact the Academy of Applied Pharmaceutical Sciences for more information on our Clinical Research, Drug Safety and Pharmacovigilance diploma program!